Blow-fill seal technology (BFS) refers to the manufacturing process used to produce various sized liquid filled vials ranging from as small as 0.1 mL to over 500 mL. Originally developed in Europe in the 1930s, it was introduced in the United States in the 1960s. Since the 1990s, BFS has become more prevalent within the pharmaceutical industry, and is now widely considered to be the superior form of aseptic processing by various medicine regulatory agencies including the U.S. Food and Drug Administration (FDA) in the packaging of pharmaceutical and healthcare products.
The basic concept of BFS is that a vial is formed, filled, and sealed in a continuous process without human intervention, in a sterile enclosed area inside a machine. Thus, BFS can be used to aseptically manufacture sterile pharmaceutical liquid dosage forms.
By way of example, machines sold under the trademark BOTTELPACK® by Rommelag® (www.rommelag.com) are used for production of various products using BFS. A machine sequence for the blow-fill seal process is described by Rommelag® as follows:
A plastic parison, extruded from polymer, is accepted by the opened blow mould and cut below the die of the parison head. The main mould closes and simultaneously seals the bottom. The special mandrel unit settles onto the neck area and forms the parison into a container using compressed air or vacuum. By way of the special mandrel unit, the product is precisely measured by the dosing unit and liquid is filled into the container. After the special mandrel unit retracts, the head mould closes and forms the required seal by vacuum. With the opening of the blow mould, the container exits from the machine and the cycle repeats itself.
U.S. Pat. No. 8,047,394 issued to Hansen discloses a safety device comprising a liquid medium which can be dispensed from a blow-molded vial utilizing the BOTTELPACK® process. In order to dispense the liquid, Hansen first requires that support points joining a head part to the vial body be broken and thereafter support points joining a head part to the vial body must be broken for removal of the head part exposing an opening for the liquid to be dispensed through. Hansen thus requires a two-step procedure for access to the liquid to be dispensed.
Hansen requires that an individual focus on the first step and once the support points of the first step have been broken, the individual can then focus on the support points of the second step. Because a child can focus its attention solely to breaking the support points of the first step and then to solely focus its attention on the second step, the current and predominant solution to making the product child-resistant is to incorporate secondary packaging. Such secondary packaging includes the use of foil wrap, over wrap, neck band, body band, etc. Unfortunately, implementation of secondary packaging increases manufacturing and labor costs, requires additional material, increases the time to manufacture, and further requires the use of multiple equipment as well as increased personnel training.
The required addition of secondary packaging which is necessary to ensure that a blow-fill seal constructed container is child-resistant has made sales of over the counter liquid medication in BFS packaging cost prohibitive.